FDA 510(k)

DNA/RNA防護收樣管

K 號：K202641 · 2020-12-14

決定日期2020-12-14

產品代碼QBD

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

DNA/RNA Shield Collection Tube is the device name listed in this FDA 510(k) record. The listed applicant is Zymo Research. It received FDA 510(k) clearance on 2020-12-14 under 510(k) number K202641. The device is classified under product code QBD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DNA/RNA Shield Collection Tube?

DNA/RNA Shield Collection Tube is a medical device that received FDA 510(k) clearance on 2020-12-14. The listed applicant is Zymo Research. The 510(k) number is K202641.

When did DNA/RNA Shield Collection Tube receive FDA 510(k) clearance?

DNA/RNA Shield Collection Tube received FDA 510(k) clearance on 2020-12-14, under 510(k) number K202641.

Who is the listed applicant for DNA/RNA Shield Collection Tube?

The FDA 510(k) record lists Zymo Research as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DNA/RNA Shield Collection Tube?

The FDA product code for DNA/RNA Shield Collection Tube is QBD.

其他以 Zymo Research 為申請人之記錄

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相關器械（代碼：QBD）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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